Chi St Vincent Oncology

Summary Statement of Deficiencies D0000 . The Laboratory was surveyed in response to Subsequent Proficiency Testing failure with the following conditions: D 2016 - 42 C. F. R. 493.803 Condition: Successful Participation: D 2017 - 42 C. F. R. 493.807 Condition: Reinstatement of Nonwaived Laboratories: D 6000 - 42 C. F. R. 493.1403 Condition: Moderate Complexity Laboratory Director: D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of 2020 and 2021 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have non-initial unsuccessful participation in proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- for the test of Blood Cell Identification (Cell I.D.). Survey findings follow: Failure to achieve satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: . Based on review of 2020 and 2021 CMS Casper Reports 155D, 153D and American Proficiency Institute (API) testing results, it was determined the laboratory had a subsequent unsuccessful performance for the test of Blood Cell Identification (Cell I. D.). Failure to achieve satisfactory performance for the test Blood Cell ID in three of four proficiency testing events. A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of Cell ID in the first proficiency testing event of 2020. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of Cell ID in the second proficiency testing event of 2020. C. A review of the proficiency testing results revealed the laboratory received a score of 10% for the test of Cell ID in the first proficiency testing event of 2021. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the 2020 and 2021 CMS Casper Reports 155D, 153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed three of four proficiency testing events which constitutes non-initial unsuccessful performance for the test of Blood Cell Identification (Cell ID). Survey findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of Cell ID in the first proficiency testing event of 2020. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the test of Cell ID in the second proficiency testing event of 2020. C. A review of the proficiency testing results revealed the laboratory received a score of 10% for the test of Cell ID in the first proficiency testing event of 2021. -- 2 of 3 -- D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on a review of the 2020 and 2021 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of 2020 and 2021 proficiency testing event results, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the analyte Blood Cell Identification. Refer to D2130 -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of the 2020 CMS Casper Reports 155D, 153D and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to participation in proficiency testing for the specialty of Hematology and each Hematology analyte. Survey Finding follow: Failure to participate in proficiency testing for the specialty of Hematology in two of two proficiency testing events results in a unsuccessful performance for each testing event as cited at D 2123. D2123 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on review of the 2020 CMS Casper Reports 155D, 153D and the American Proficiency testing results, it was determined the laboratory failed to participate in the first and second proficiency testing events of 2020, resulting in a score of 0% for the specialty of Hematology and each Hematology analyte. Survey Findings Follow: A. The laboratory received a of 0% for the speciality of Hematology in the first and second proficiency testing event of 2020. B. The laboratory received a score of 0% for the test of White Blood Cell Differential, Red Blood Cell Count, Hemoglobin, Hematocrit, Platelets and White Blood Cell Count in the first and the second proficiency testing event of 2020. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on a review of the 2020 proficiency testing results, it was determined the Laboratory Director failed to ensure that

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation , a lack of documentation and interview with laboratory staff it was determined that the laboratory failed to define and monitor the conditions for proper storage of reagents and supplies consistent with manufacturer ' s instructions in one of two rooms in which supplies with storage temperature requirements were stored. Survey findings follow: A.On a tour of the facility conducted at approximately 1100 on 4/4/19, a flat of 100 BD EDTA blood collection tubes, lot # 8187713 expiration date 2019-12-31 , a flat of 100 BD SST blood collection tubes lot # 8255925 expiration date 2019-8-31 and a flat of 100 BD Na Citrate blood collection tubes lot # 8215583 expiration date 2019-5-31 all with storage temperature requirement of 4 degrees C. to 25 degrees C. were observed in a room separated from the main laboratory room by a closable door. B.Temperature and humidity records reviewed lacked documentation of data for the storage room mentioned above. C. Upon request, the laboratory was unable to provide documentation of room temperatures for the room identified above. D. In an interview on 4/4/19 at approximately 12:00 PM the technical consultant identified as number 2 on the CMS 209 form confirmed that room temperatures were not monitored for the storage room identified above.. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observation and interview it was determined that the laboratory had 127 BD EDTA blood collection tubes and 118 BD Heparin blood collection tubes available for use that exceeded their date of expiration. Findings follow: A. During a tour of the laboratory on 4/4/19 at approximately 11:45 AM ,the surveyor observed 127 BD 4.5 ml. EDTA, lot # 8099550, with an expiration date of 2019-1-31 and 118 BD Heparin blood collection tubes lot # 7279847 with an expiration date of 2019-3-31 in a storage cabinet in the laboratory. B. In an interview on 4/4/19 at approximately 12:30 PM, the technical consultant identified as number 2 on the CMS 209 form confirmed that the tubes identified above had exceeded their expiration date and were available for use. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through review of the laboratory's policy and procedure for quality control, individual CBC quality control reports , lack of documentation and interview it was determined that the laboratory reported 48 patient CBC results without performing required quality control on one of 21 days of operation in July 2018. Findings follow: A. Review of the laboratory's policy and procedure for quality control revealed that at least two of three levels of quality controls must be within acceptable range before patient testing can be performed and patient results released. B. Review of individual quality control reports for 7/2/2018 revealed that abnormal high level control lot# 2180323 was recorded as giving unacceptable high results for hemoglobin and mean corpuscular hemoglobin analysis, normal level control lot # 2180322 was recorded with no values and only a flag of "DF" which indicated an analyzer malfunction, and abnormal low control lot # 2180321 was recorded with no values and only a flag of "DF" which indicated an analyzer malfunction. C. Review of patient CBC result reports revealed that CBC analyses were performed and reported on 48 patients identified as numbers 1 through 48 on the "Provider Schedule for Monday, 7/2/2018. D. In an interview on 4/4/19 at approximately 12:30 PM the technical consultant identified as number 2 on the CMS 209 form and the laboratory testing personnel identified as number 3 on the CMS 209 form confirmed that a CBC's were performed and reported on 7/2/18 without the required successful quality control results. -- 2 of 2 --